(1) Field of the Invention.
This invention relates broadly to providing medicinal injections into the human body and particularly medicinal injections self-administered by the patient such as insulin injections. More particularly, the invention relates to devices for retracting or puckering the flesh at the surface of the body in order to provide subcutaneous injections of medicinal materials.
(2) Description of the Prior Art
Injections into the human body may be broadly classified into three separate categories:
(A) Intravenous injections which are provided directly into the blood stream or into a blood vessel. Intravenous injections are often given with the same or similar apparatus as is used for drawing blood from the human body for medical analysis purposes.
(B) Subcutaneous injections are provided into the tissue just under the skin. Subcutaneous injections are given when it is desired to apply a medicinal substance to the body without having it immediately disbursed in the blood to other parts of the body. Subcutaneous injections usually provide a slower release of a medicinal substance into the body and thus guard against over-reaction in other portions of the body. Intramuscular injections may be occasionally characterized as subcutaneous injections, although the typical subcutaneous injection is into the fascia and fat tissue just under the skin.
(C) Deep tissue injections are made to internal organs such as, for example, to the heart muscle or other muscles of the body or to other non-muscular organs. Deep tissue injection is rather closely related to needle-type biopsy and it is consequently often applied with similar devices and apparatus except for the size of the needle or trocar.
Deep tissue injections usually are given directly without the aid of any external apparatus other than a long needle or trocar. Occasionally an indexing device for positioning the needle or trocar with respect to external portions of the body in order to more effectively direct an injection into specific internal organs is used.
Intravenous injections are often administered without the use of any external apparatus other than the skilled hands of a technician and the necessary hypodermic needle. However, devices have also been developed for aiding in the administration of such injections. Most such devices have been designed to aid in isolating a suitable vein near the surface of the body in order to facilitate the injection. While the best device for locating suitable veins is still the sight and feel of a skilled technician, mechanical devices can sometimes aid in such endeavors, particularly when used by less experienced technicians.
With respect to subcutaneous injections, it is customary, in many cases, to pucker the flesh prior to applying the injection. Puckering the flesh has two main purposes. First, it isolates the portion of the body into which the injection is intended to be made and prevents the injection from inadvertently being made into underlying organs such as the muscles and the like where it might enter a large blood vessel prematurely. Puckering the flesh at the surface of the body essentially isolates the skin and its associated underlying structures including a subcutaneous adipose tissue or fat layer at the surface of the body. Puckering of the flesh also, in effect, hardens or firms that portion of the surface fascia facilitating insertion of the injection needle.
A medical person such as a doctor or nurse will usually pucker the flesh with the fingers of one hand while applying the injection with the other hand. However, many injections, and insulin injections in particular, are applied by the patient him or herself since the frequency of the required injections mitigates against having a third party administer such injections. To have a medical person provide such injections would be prohibitively expensive unless such medical person was a member of the patient's family. While other members of a patient's family may also be able to apply insulin injections, this also is frequently inconvenient since an experienced hypodermic user in the patient's own family is not always present when the patients medical injections are required. Consequently, it is customary for diabetes patients, if physically capable, to learn to administer their own injections of insulin. The same is true of patients requiring a few other medicinal substances that are provided by injection.
While it is possible for a patient to use two hands (assuming such patient has two operable hands) to inject medicinal substances into his own body such as into his thighs or abdominal area, it is physically impossible for a patient, using the flesh puckering technique, to make injections into his arms. This is because it is quite impossible for the normal person to reach a large portion of his arm with the hand of the same arm. Consequently, a number of devices have been developed for puckering the flesh prior to making an injection into such puckered flesh portion. Among such devices may be listed the following:
U.S. Pat. No. 1,934,046 issued Nov. 7, 1933 to M. DeMarchi discloses a vacuum-type apparatus arrangement for drawing the flesh of the body toward a hypodermic needle.
U.S. Pat. 2,660,169 issued Nov. 24, 1953 to H. Malm discloses a hypodermic syringe which includes two forcep or tweezer-like arms which may be used to gather or pucker flesh that may then be injected by a hypodermic needle positioned between the ends of the tweezer-like arms. Such arms have blunt ends which directly contact the flesh.
U.S. Pat. 2,704,071 issued Mar. 15, 1955 to P. Becker discloses a skin retractor for giving subcutaneous injections of adrenalin, insulin or formula B-12 for the treatment of pernicious anemia and the like. The device is said to be designed especially for subcutaneous injections rather than intravenous injections. The Becker device is essentially a conventional spring-clip having more or less U-shaped jaws with plastic surfaces. The top of the clip is provided with a lariat-type arrangement for holding with the hand to actively pull the clip and clamped skin between the jaws of the clip away from the body to facilitate injection.
U.S. Pat. 3,760,803 issued Sept. 25, 1973 to L. S. Boothby discloses a clamp designed to be applied to a body member such as an arm for self-injection of insulin or the like. The clip completely surrounds the arm and is provided with two transversely elongated jaws which may have compressible pads upon the surfaces. The spring-clip tends to compress a mound of flesh between the jaws to facilitate injection of a medicinal material into such flesh. It appears the Boothby self-injection clamp would not be particularly convenient to apply since the arm must first be inserted through the opening in the clamp.
U.S. Pat. No. 4,223,673 issued Sept. 23, 1980 to W. J. Harris discloses a flesh-puckering clamp used for injection of subcutaneous substances. The clamp is provided with a pair of handles for expanding the jaws for application to the body. The jaws completely surround the arm and pucker the flesh on the opposite side of the arm from the handles.
U.S. Pat. 4,634,429 issued Jan. 6, 1987 to G. L. Schoettley discloses an arm encircling clamp arrangement for expediting self-injection of insulin and the like. The Schoettley clamp differs from the Boothby and Harris clamps in that the two jaws of Schoettley's clamp are not duplicates of each other, but are different. The one jaw is said to provide a broad surface against or upon which the opposing jaw tends to roll the flesh of the body providing a better support of said flesh for injection purposes.
Other devices which draw the flesh into a mound or pucker by vacuum means in order to facilitate insertion of a hypodermic needle are disclosed in U.S. Pat. Nos. 2,743,723, issued May 1, 1956 to G. N. Hein and U.S. Pat. No. 2,945,496 issued Jul. 19, 1960 to A. Fosdal, the latter being designed especially for use in dentistry.
Among prior patents that have been designed especially for facilitating intravenous injections may be mentioned the following:
U.S. Pat. No. 1,561,116 to J. C. Silliman (1925) PA0 U.S. Pat. No. 2,103,174 to V. M. Posada (1937) PA0 U.S. Pat. No. 3,324,854 to W. W. Weese (1967) PA0 U.S. Pat. No. 4,299,219 to G. P. Norris (1981) PA0 U.S. Pat. No. 4,314,568 to J. A. Loving (1982) PA0 U.S. Pat. No. 4,586,924 to C. T. Lanning (1986)
The Norris device is a vacuum-type device, while the others are body surface pressure-type devices designed to accentuate a vein at the surface by single point constriction and lateral isolation.
While the prior art devices for providing subcutaneous injections, particularly by the patient himself, have been effective within their limitations, they have been by and large complicated, expensive, difficult to use, or not as effective as desired.